21 CFR 862.3900 — Bacillus Subtilis Microbiology Assay, Tobramycin
Clinical Toxicology (TX) · Subpart D—Clinical Toxicology Test Systems · § 862.3900
Identification
A tobramycin test system is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DID | Bacillus Subtilis Microbiology Assay, Tobramycin | 2 | 5 | 3rd Party |
| KLB | Radioimmunoassay, Tobramycin | 2 | 23 | 3rd Party |
| KZX | Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Tobramycin | 2 | 0 | 3rd Party |
| LCR | Fluorescent Immunoassay, Tobramycin | 2 | 17 | 3rd Party |
| LDO | Enzymatic Radiochemical Assay, Tobramycin | 2 | 3 | 3rd Party |
| LFW | Fluorescence Polarization Immunoassay, Tobramycin | 2 | 10 | 3rd Party |
